Feasibility Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Treatment of Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00269152
First received: December 21, 2005
Last updated: July 15, 2014
Last verified: July 2014

December 21, 2005
July 15, 2014
December 2005
November 2007   (final data collection date for primary outcome measure)
The Feasibility of Post-Surgery Chemotherapy [ Time Frame: every 21-day cycle for 4 cycles up to 30 days after last infusion ] [ Designated as safety issue: Yes ]
Feasibility was measured by completion of 4 treatment cycles without remaining toxicities >=Grade 3 at 30 days after last infusion.
The treatment regimen is considered "feasible" for a patient, if this patient is being able to follow the treatment administrations per protocol for 4 consecutive cycles.
Complete list of historical versions of study NCT00269152 on ClinicalTrials.gov Archive Site
  • Grade III/IV Adverse Events [ Time Frame: every 21-day cycle for 4 cycles ] [ Designated as safety issue: Yes ]
    Number of participants experiencing Grade III/IV hematologic and non-hematologic adverse events possibly related to study drug or protocol procedures in this study.
  • Overall Survival at 3 Years [ Time Frame: baseline to date of death from any cause, assessed at 3 years ] [ Designated as safety issue: Yes ]
    For each treatment arm, the Kaplan-Meier technique was used to estimate the 3 year survival rate. Results are presented as probability (%) of survival at 3 years. Overall survival is the duration from enrollment to death. For participants not known to have died, overall survival was censored at the last known alive date.
  • 3 Year Disease-Free Survival: Probability of Disease-Free Survival at 3 Years [ Time Frame: length of time disease free, assessed at 3 years ] [ Designated as safety issue: No ]
    For each treatment arm, the Kaplan-Meier technique was used to estimate the 3 year disease-free rate. Disease-free survival is defined as the time from enrollment to the first observation of disease progression, or death due to any cause. For participants not known to have died and to have had recurrent disease, disease-free survival was censored at the date of the last participant contact with No Recurrence status. Results are presented as probability (%) of disease-free survival at 3 years.
  • Overall Survival at 6 Years [ Time Frame: Baseline to date of death from any cause assessed at 6 years ] [ Designated as safety issue: Yes ]
    For each treatment arm, the Kaplan-Meier technique was used to estimate the 6 year survival rate. Results are presented as probability (%) of survival at 6 years. Overall survival is the duration from enrollment to death. For participants not known to have died, overall survival was censored at the last known alive date.
  • To characterize the quantitative and qualitative potential toxicities and the necessity of dose reductions and cycle delays due to toxicities of either treatment arm.
  • To assess time to event efficacy parameters in both treatment arms including
  • Overall survival (assessed after 3 years).
  • 3 year disease free survival.
  • To assess biomarkers relevant to pemetrexed and disease state and their correlation to clinical outcome (including overall survival, 3 year disease free survival and toxicity).
Not Provided
Not Provided
 
Feasibility Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Treatment of Non-Small Cell Lung Cancer
A Randomized Phase 2 Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Chemotherapy in Patients With Completely Resected Stage Ib or II Non-Small Cell Lung Cancer

This study is a multicenter, open-label, two-arm, randomized, parallel Phase 2 feasibility study of pemetrexed in combination with either cisplatin (Arm A) or carboplatin (Arm B) as adjuvant combination-chemotherapy in participants with completely resected, stage Ib or IIa/IIb non-small cell lung cancer (NSCLC).

A two-stage design will be employed independently for both treatment arms, with the possibility of stopping each treatment early for lack of feasibility.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: pemetrexed
    500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 4 cycles
    Other Names:
    • LY231514
    • Alimta
  • Drug: cisplatin
    75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
  • Drug: carboplatin
    area under the curve (AUC) 5 milligrams per milliliter*minute (mg/ml*min), intravenous (IV), every 21 days x 4 cycles
  • Experimental: A: Pemetrexed + Cisplatin
    Interventions:
    • Drug: pemetrexed
    • Drug: cisplatin
  • Experimental: B: Pemetrexed + Carboplatin
    Interventions:
    • Drug: pemetrexed
    • Drug: carboplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
July 2013
November 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically proven non-small cell lung cancer stage Ib, IIa or IIb
  • Must have complete tumor resection by pneumonectomy or lobectomy
  • Must have been surgically proven to be N2 negative

Exclusion Criteria:

  • Serious concomitant systemic disorder
  • Post-operative complications or other surgery related conditions
  • A prior malignancy other than NSCLC unless that malignancy was diagnosed and treated at least 5 years ago
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   France,   Spain
 
NCT00269152
10105, H3E-SB-S089
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Chair: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP